Status Flu A+B Validation Kit BSP-510-22-08

GUDID 10743816001430

Status Flu A+B Validation Kit; 22 Tests, 10 Positive Swabs, 10 Negative Swabs, 2 Regular Swabs

PRINCETON BIOMEDITECH CORPORATION

Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: 10743816001430
• NIH Device Record Key: cd84c7b0-9faf-4390-b986-e177ccbfe739
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Status Flu A+B Validation Kit
• Version Model Number: BSP-510-22-08
• Catalog Number: BSP-510-22-08
• Company DUNS: 362917692
• Company Name: PRINCETON BIOMEDITECH CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18005262126
• Email: info@lifesignmed.com
• Phone: 18005262126
• Email: info@lifesignmed.com
• Phone: 18005262126
• Email: info@lifesignmed.com
• Phone: 18005262126
• Email: info@lifesignmed.com
• Phone: 18005262126
• Email: info@lifesignmed.com
• Phone: 18005262126
• Email: info@lifesignmed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10743816001430 [Primary]

FDA Product Code

• GNX: Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-06-10
• Device Publish Date: 2017-05-10

Devices Manufactured by PRINCETON BIOMEDITECH CORPORATION

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• 10743816001645 - Status™ COVID-19 Antigen Rapid Test for Home Use: 2023-10-30 Status™ COVID-19 Antigen for Home Use, 25 Test Kit
• 10743816000532 - BioSign® hCG card: 2023-07-06 BioSign® hCG card; 35 Test kit
• 10743816000556 - Status hCG card: 2023-07-06 Status hCG card; 35 Test kit
• 10743816000563 - Status hCG card: 2023-07-06 Status hCG card; 12 Test sample kit
• 10743816000570 - BioSign® hCG card: 2023-07-06 BioSign® hCG card; 35 Test kit; CE
• 10743816000587 - BioSign® hCG card: 2023-07-06 BioSign® hCG card; 10 Test kit; CE